Status:
TERMINATED
The Better Resiliency Among Veterans With Omega-3's (BRAVO) Study
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Suicide
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal thinking, negative e...
Detailed Description
The BRAVO study seeks to determine if dietary supplementation with omega-3 highly unsaturated fatty acids (omega-3 HUFAs) reduces the risk for serious suicidal behaviors, suicidal thinking, negative e...
Eligibility Criteria
Inclusion
- Inclusion criteria- Primary study
- a Veteran or non-Veteran identified as being at risk for suicide and presently under the care of a mental healthcare provider (A release of information from his/her mental healthcare provider is required.)
- age 18 - 90
- within the participant's medical history, either
- a suicide attempt in the last 6 months, or
- a suicide attempt during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or
- an inpatient admission with suicide risk in the last 6 months, or
- an inpatient admission with suicide risk during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or
- positive suicidal behavior or ideation based on a psychiatrist- administered Columbia-Suicide Severity Rating Scale (C-SSRS) and psychiatrist review of participant medical history and physical\], or
- a score of 0 or greater on the Implicit Associations Test-Suicide (IAT-S), or
- \> or = 9 on the Beck Hopelessness Scale (BHS) and psychiatrist review of participant medical history and physical
- participant can safely eat walnuts, pecans, almonds, peanuts and all other nuts
- participant can safely eat apples, peaches, pears, pomegranates, aronia, jackfruit, and passion fruit
- participant can safely eat the herb rosemary, and the fish salmon, trout and cod
- participant can safely drink and eat food that contain whey and/or milk protein
- willingness to drink the juice boxes 3 times each day for 6 months
- have a stable residence with adequate space to store the juice
- capacity to provide written informed consent
- Additional inclusion criteria for Depressive Symptoms sub-analysis
- enrollment in the primary study of suicide risk reduction
- a Beck Depression Inventory ≥30
- a diagnosis of a depressive disorder
- Additional inclusion criteria for Alcohol and Nicotine use sub-analysis
- enrollment in the primary study of suicide risk reduction
- diagnosis of an alcohol use disorder or "at risk drinking patterns"
- self-report of smoking \>10 cigarettes/d.
- Exclusion criteria-
- unstable medical conditions requiring immediate attention or medical conditions that preclude potential study participation for the duration of the study
- history of seizures, except for:
- febrile seizures during childhood
- history of a single seizure episode as an adult if not being maintained on anti-seizure medication; this single seizure must not be related to a primary seizure disorder (must not be epilepsy)
- persons who have received a diagnosis of diabetes
- those taking Isotretinoin (Accutane)
- allergy, hypersensitivity, or intolerance to fish oils or omega-3 fats
- allergy, hypersensitivity, or intolerance to Macadamia nuts or any nuts such as almonds, walnuts, pecans, peanuts, etc.
- allergy, hypersensitivity, or intolerance to apples, peaches, pears, pomegranates, aronia, jackfruit, and passion fruit
- allergy, hypersensitivity, or intolerance to the herb rosemary, and the fish: salmon, trout and cod
- allergy, hypersensitivity, or intolerance to whey and/or milk protein
- life threatening medical conditions or life expectancy of less than 6 months
- pregnancy or lactation or intention to become pregnant within the next 12 months
- acute intoxication or withdrawal from alcohol or other substances (to be determined by a clinical team member)
- a cognitive impairment severe enough to preclude informed consent or valid responses on self-report questionnaires
- Body Mass Index (BMI) \<18 or \>45
- evidence of disordered eating or risk of malnutrition based on the Eating Attitudes Test (EAT-26)
- relapsing of remitting Multiple Sclerosis
- unstable or rapidly progressive neurological disease
- history of significant behavioral instability
- participating in another research study
- regular use of anticoagulants such as high dose aspirin, warfarin or Coumadin
- take hypoglycemic agents
- Additional exclusion criteria for fMRI Study only (40 individuals)
- inability or unwillingness to participate in an fMRI scan
- presence of metallic objects in the body that would interfere with the scan
- pronounced claustrophobia
- body weight \>300 pounds
Exclusion
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2016
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01901887
Start Date
March 1 2014
End Date
August 30 2016
Last Update
June 12 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425